OBJECTIVE: This study aimed to determine the health-related quality of life among patients with type II diabetes mellitus (T2DM) using insulin therapy.

METHODS: Cross-sectional observational study design was used to collect data from Malaysian patients with T2DM. Subjective and objective assessments were made either by using several questionnaires or each patient's specific medication profile registered to care sites. Study participants were recruited from both public hospitals and community health clinics located in Kuala Lumpur, Malaysia.

RESULTS: A total of 430 patients with T2DM were recruited in this study with a response rate of 94.7%. The oral antidiabetic medication (OAM) group consisted of 63.0% of the study population and the rest (37.0%) were Insulin users. The body mass index and glycosylated hemoglobin patterns were significantly different between groups (P < 0.011 and P < 0.001). Insulin users showed high percentages of healthy body mass index index (44.7%) compared with OAM users (35.8%) and controlled glycemic index (glycosylated hemoglobin ≤7.5%) was significantly (P = 0.001) better among the insulin-user group compared with the OAM group. The Euro Quality of Life-5 dimension domain analysis indicated significant differences with domains of usual work (P < 0.047), pain and discomfort (P < 0.041), and anxiety and depression (P < 0.001) among insulin users versus OAM users. We also observed a significant difference between the groups regarding diet, monitoring, and disease-specific knowledge. The mean (SD) adherence score showed that insulin users were significantly (P < 0.001) more adherent (6.09 [2.98]) than OAM were nonadherent (4.19 [4.68]).

Methods: A multi-center cross sectional study was conducted for a month in out-patient wards of hospitals in Khobar, Dammam, Makkah, and Madinah, Saudi Arabia. Patients were randomly selected from a registered patient pools at hospitals and the item-subject ratio was kept at 1:20. The tool was assessed for factorial, construct, convergent, known group and predictive validities as well as, reliability and internal consistency of scale were also evaluated. Sensitivity, specificity, and accuracy were also evaluated. Data were analyzed using SPSS v24 and MedCalc v19.2. The study was approved by concerned ethics committees (IRB-129-25/6/1439) and (IRB-2019-05-002).

Results: A total of 282 responses were received. The values for normed fit index (NFI), comparative fit index (CFI), Tucker Lewis index (TLI) and incremental fit index (IFI) were 0.960, 0.979, 0.954 and 0.980. All values were >0.95. The value for root mean square error of approximation (RMSEA) was 0.059, i.e., <0.06. Hence, factorial validity was established. The average factor loading of the scale was 0.725, i.e., >0.7, that established convergent validity. Known group validity was established by obtaining significant p-value <0.05, for the associations based on hypotheses. Cronbach's α was 0.865, i.e., >0.7. Predictive validity was established by evaluating odds ratios (OR) of demographic factors with adherence score using logistic regression. Sensitivity was 78.16%, specificity was 76.85% and, accuracy of the tool was 77.66%, i.e., >70%.